19-01 National Flexible Bradford Packaging BRC Audit Report Rev 2€¦ · of film with barrier coating and antifog properties for the food and beverage industries. Exclusions from

If you would like to feedback comments on the BRC Global Standard or the audit process directly to BRC, please contact [email protected]

P501: Packaging 5 High Hygiene, Issue 2 Dec 2015. Report No.: UK/BRC/084 Auditor: Laurence Powell

QA International Certification Ltd, Dudley Court, Dudley Road, Darlington, Co.Durham, DL1 4GG This report shall not be reproduced in part without the permission of QA International Certification Ltd

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Audit Report Global Standard Packaging and Packaging Materials Issue 5: July 2015

Audit summary

Company name National Flexible Ltd BRC site code 2113728

Site name Bradford

Hygiene Category High Hygiene

Audit scope

Scope of audit The slitting, rewinding and hot needle perforation of sub contracted flexographic printed or plain laminated, polypropylene, polyethylene, amorphous polyethylene Terephthalate, polyamide, (polyester) Surlyn, metallised; APET, OPA, EVOH, OPP, LLDPE, PVdC into reels of film with barrier coating and antifog properties for the food and beverage industries.

Exclusions from scope None

Justification for exclusion None

Voluntary modules included

Modules Result Details

Choose a module Choose an item

Choose a module Choose an item

Audit results

Audit result Certificated Audit type Announced

Audit grade AA Previous audit grade AA

Number of non‐conformities Major against SOI of Fundamental 0

Critical 0

Major 0

Minor 4




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Company details

Address 2 Battlefield View, Birkenshaw, Bradford BD11 2PT

Country UK Telephone 01274 685566

Commercial representative Name

Carol Burdett Email [email protected]

Technical representative Name

Caroline Clay Email [email protected]

Company profile

Plant size (square metres)

<10K sq.m No. of employees

1‐50 No. of key processes

1‐3

Subcontracted processes Yes

Other certificates held ISO 9001:2015

Regions exported to Europe

Major changes or auditor observations since last BRC audit

No major changes since the last audit

Company description The company was established over 40 years ago and became part of the Charles Baynes group in 1993. In 1998 Barry Twigg the current chairman undertook an MBO and National Flexible has evolved into a high‐quality supplier of flexible films owned by its management and staff and is located on a light industrial estate in Birkenshaw, to the south‐east of Bradford. The company supplies a wide range of laminated, polypropylene, polyethylene, amorphous polyethylene Terephthalate, polyamide, metallised; APET, OPA, EVOH, OPP, LLDPE, PVdC plain and printed film primarily for the UK and the EU. Films are purchased, the artwork process is managed in‐house and printing and lamination is outsourced to meet customers’ specific needs. Stock is held on site and called off by customers when required to give a rapid response. The company support and fund both on the job training and general interest training for all employees and have excellent staff engagement. The buildings comprise an area of 2,415 square metres. The site is entirely suited to the production and supply of food grade packaging products. There are 45




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Company profile

personnel operating a rotating shift system and are no more than 35 employees on site at any one time. The Directors mission is to establish an operation at the forefront of technology, selling high quality ,safe and legal packaging products. The technical team continually offers advice on new or alternative films to extend customers products shelf life. The systems and management of the company meet the requirements of the BRC Global standard for packaging and packaging materials issue 5.

Product and process characteristics

Field of Audit (Glass Paper Metal Rigid plastic Flexible plastic Wood and other material Print Chemical processes)

05 ‐ Flexible plastics Category Category Category Category Category Category

Products in production at the time of the audit

Printed and plain films of varying materials and sizes slit and perforated for confectionery and snack foods

Audit duration details

Finish date 2019‐01‐29

Re‐audit due date 2020‐02‐22 Previous audit date 2018‐01‐30

On‐site duration 12 hours Duration of production facility inspection

4 hours

Reasons for deviation from typical or expected audit duration

No deviation P509 Compliant

Next audit type selected Announced




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Audit duration per day

Audit days Date Audit start time Audit finish time

1 (start date) 2019‐01‐28 09:00 17:00

2 2019‐01‐29 08.45 12.45

Auditor information

Auditor number Auditor Name Role

110034 Laurence Powell Sole Auditor

Present at audit Note: the most senior operations manager on site should be listed first and be present at both opening & closing

meetings (ref: clause 1.1.7) Opening meeting

Site inspection

Procedure review

Closing meeting

Name / Job Title

Mark Thomson, Operations Director X X

Caroline Clay, Quality Manager X X X X

Andy Burden, Operations Manager X X X

Scott McEvoy, Technical Engineer X X

Ryan Serle, Graphic Designer X X

Simon Bartoft ,Production Supervisor X X

Charlie Abel, Production Operator X

Tony Barker, Operator X

Josh Machin, Warehouse Operator X

If you would like to feedback comments on the BRC Global Standard or the audit process directly to BRC, contact [email protected]

P501: Packaging 5 High Hygiene, Issue 2 Dec 2015. Report No. UK/BRC/084 Auditor: Laurence Powell


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Non‐Conformity Summary

Major non‐conformity against statement of intent of a fundamental requirements

No. Requirement ref.

Details of non‐conformity Critical or Major ? Anticipated re‐audit date

Critical

No. Clause. Details of non‐conformity Anticipated re‐audit date

Major

No. Clause Details of non‐conformity Correction Proposed preventive action plan (based on root cause analysis)

Evidence provided document, photograph, visit/other

Date reviewed

Reviewed by




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Minor



Date reviewed

Reviewed by

1 2.2.5 The site has not carried out a food fraud or food defence risk evaluation

Reviewed P552 position statement

Review Appendix 5 of our HACCP Plan and amend to include “Food Fraud & Food Defence

Updated copy of HACCP and Appendix 5 Risk Assessment See enclosed

2019‐02‐21

Laurence Powell

2 4.6.3

Wooden equipment including pallets and storage boxes were splintering posing a risk of contamination

Reviewed wood policy, arranged in house training covering condition of pallets and clean as you go policy

Restrict wood in production areas where reasonably practicable Monitor condition of pallets within warehouse and production area’s

Wooded storage Box has now been removed (see photo) Tool box Training session has been held to reinforce our wood policy, covering checks on Good in/Out procedures see enclosed documents

2019‐02‐21

Laurence Powell

3 4.7.6

Temporary repairs using blue tape on Machine S37, were not recorded on temporary engineering log

Reviewed in house training regarding inspection pad completion and arranged tool box talks

Re issue Tool Box training covering the importance of reviewing any temporary repairs needed

Tool Box Talk held with production operators see enclosed evidence

2019‐02‐21

Laurence Powell

4 4.8.4

Cleaning equipment for toilets was not segregated from those used elsewhere and the cleaner’s cabinet was not locked

Reviewed our contract Cleaners policy, procedures and on‐site training programme

Full review to confirm cleaner on site at National Flexible has been trained in the correct segregation of cleaning equipment

Colour Coding identification signRisk Assessment & Training sheet both enclosed New Mops and Buckets have now been supplied by Active Cleaning

2019‐02‐21

Laurence Powell

Comments on non‐conformities – not tagged, just free text. This is to explain where a large number of NCs have been raised without a major




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Voluntary Modules Non‐Conformity Summary Sheet

Critical

No. Clause Details of non‐conformity Anticipated re‐audit date




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Major


Evidence provided: document, photograph, visit, other

Date reviewed

Reviewed by




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Minor



Date reviewed

Reviewed by




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Detailed Section

1. Senior management commitment

1.1 Senior management commitment and continual improvement

The companies site Quality & Product Safety Policy QM001 at issue 8, date 03.01.2019 signed by George Slack, managing director incorporates company commitment of safe and legal product, regulatory compliance, continual quality improvements and is compliant with the requirements of the standard. The policy is displayed at various site locations including reception and included within the company Quality Manual. The policy is communicated to all staff on notice boards and through the staff induction program. The policy is reviewed for suitability as part of the annual management review process. There are objectives in place set at the annual Management Review meeting , QM002 at issue 2, date 20.09.2017 for the coming year with last review on 25.01.2019 by George Slack. There are product safety and quality targets in place, some examples being: ‐

Customer Complaints not to exceed 1.05% of all orders placed, 1.07% in 2017.

Maintain AA grade for BRC audit

Internal audits completed on time to schedule

Corrective actions to be completed within 28 days

Operators to be all trained in fundemental principles of HACCP There is a dedicated BRC Management Representative on site in the form of Caroline Clay, Quality Manager with Toni Leach, QA Assistant as the dedicated BRC Deputy. The BRC team are fully supported by senior and departmental management. Adequate personnel and financial resources are provided at site by the senior management to ensure the standard is fully implemented. The site has several systems in place to engage employees and ensure continual improvement is progressed including a suggestion scheme, a risks, opportunities & CI register, and supports and funds all training both job related and to broadly enhance staff skill. The site reviews food safety alerts and EC Legislation changes and subscribe to Packaging News, Plastics Weekly and websites such as the BRC website, the government website for food contact materials (www.food.gov.uk) and the European Website for food safety (ec.europa.eu) are regularly reviewed. The site holds documentation with supporting compliance to EC legislation 1935/2004, 2023/2006, EU10/2011 and amendments, company and supplier’s declaration of compliance and suppliers of raw material food contact statements. Declarations of Compliance are in place for all products produced at the site which are sent to customers on request. Product specification sheets are produced for each individual product. Products are sold within the UK and Europe and conform to legislation. External migration testing is undertaken by suppliers or recognised laboratories on a regular basis. Migration report dated 22.10.2018 viewed during the assessment from Lab Analysis s.r.l, testing Clear BOPP Film both sides Acrylic Coated, report number 1320065/01 which met the global migration limits laid down in the EU10/2011 Directive. There is a genuine electronic copy of issue 5 of the standard in place. The company has a system to ensure re‐certification occurs on or before the audit due date and this audit took place within the required timeframe. The operations director was present at the opening and closing meeting and all relevant personnel were on site and available during the assessment. The Company has a system to close out non‐conformities raised in internal, second‐party and third‐party audits, which considers root cause. Non‐conformance are created from customer complaints, external audits, second‐party audits, third‐party audits, internal audits and are reviewed at weekly production and quality meetings and monthly quality meetings with attendees including




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the senior management. Internal non‐conformance and root cause analysis is evident in the closure of the reports. Non‐conformities raised at last year’s audit have been effectively closed out using root cause analysis. All personnel had been briefed that the audit was taking place. Audit Evidence;

Doc. ID :‐ Quality & Product Safety Policy QM001 at issue 8, date 03.01.2019, signed by George Slack Doc. ID :‐ Objectives QM002 at issue 2, date 20.09.2017, last review on 25.01.2019 by George Slack. Doc. ID :‐ Regulatory Compliance Certificate, date 23.07.2018 signed by Scott McEvoy Technical Engineer Doc. ID :‐ Risks, opportunities & CI register , SOP 012.4 at issue 4, date 02.01.2019 Management review meeting minutes date 14.08.2018 Monthly QA meeting minutes , date 23.01.2019 Weekly production and quality ,meeting minutes, date 25.01.2019 Previous BRC audit report dated 30.01.2018 with completed non‐conformances including root cause Migration report dated 22.10.2018 from Lab Analysis s.r.l, testing Clear BOPP Film both sides Acrylic Coated, report number 1320065/01 with migration limits conforming to guidelines set down in EU10/2011.

1.2 Management review

There is an annual Management Review Meeting undertaken at the site. The last meeting was conducted on the 14.08.2018, documented on SOP012.5 at issue 5 ,date 12.06.2018. Present at the meeting was the M.D., Commercial Director, Quality Manager, QA Assistant & Technical Engineer. The minutes were reviewed during the assessment and the agenda items were found to meet the requirements of the standard and included as examples: ‐

Previous minutes

Changes in external and internal issues relevant to QMS

Customer feedback/complaints/satisfaction

Objectives

HARM Review

N/C’s and corrective actions

Monitoring and measurement results

Audit results

Performance of external providers

Recources

Actions to address risks

Opportunities for improvement The process reviews targets and objectives annually and through monthly meetings and any actions needed are tracked to completion. Minutes are circulated to all attendees with action points allocated to designated personnel under further action and closed effectively. Examples being HACCP review needed, action HACCP team, closed 31.08.2018 and supplier performance review Gardener, action Andrew Burden, closed 06.09.2018 The review communicated to all staff. The Non‐Conforming Product Procedure is used to manage incidents. There is a reporting system in place for site personnel in relation to raising product safety quality & legality through weekly quality and production meetings with senior management in attendance at all meetings. Audit Evidence; Doc. ID :‐ Management Review Meeting Minutes, date 14.08.2018, documented on SOP012.5 at issue 5, date 12.06.2018




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Monthly QA meeting minutes , date 23.01.2019Weekly production and quality meeting minutes, date 25.01.2019

1.3 Organisational structure, responsibilities and management authority

There is a documented Organogram in place Doc. Ref. SOP 16 at issue 018, date 14.01.2019. The chart is displayed as a tiered structure starting at the CEO and M.D. and ending at the Production Operatives. Key personnel are displayed along with clearly defined reporting channels. Key personnel are displayed along with clearly defined roles, responsibilities, reporting channels and identifying personnel responsible for product safety, legality, regulatory compliance, quality and the deputies. All key staff are aware of their responsibilities within the company and roles and resources reviewed annually at the management review. There is a dedicated BRC Management Representative on site in the form of Caroline Clay, Quality Manager and Toni Leach, QA Assistant as the BRC Deputy. Job descriptions are in place and issued to all personnel upon commencement of employment. All key staff are aware of their responsibilities within the company via a site induction and job specific on‐the‐job training with refresher training as required. Work instructions are issued for each job. Audit Evidence; Doc. ID :‐ Organogram in place Doc. Ref. SOP 16 at issue 018, date 14.01.2019 Reviewed customer champion job description includes responsibility for all quality issues pertaining to purchasing of raw materials , managing customer trial reels and completing customer enquiry forms

Non‐applicable clauses None

2. Hazard and risk management system

2.1 Hazard and risk management team

There is a multi‐disciplinary HARM Team in place at the site with Toni Leach, QA assistant as the team leader and is formally trained in HACPP Principles. There are six members of the HARM Team, Scott McEvoy, Technical Engineer, Andrew Burden, Operations Manager, George Barker, Customer Champion, Tony Barker, Machine Operator, Toni Leach , QA Assistant and Bolu Fagboran, Warehouse Manager. All team members have been formally trained in HACCP principles and certificates are in place at the site. All team members have extensive experience of food packaging manufacturing operations. There is no need for external expertise for the maintenance of the HARM System. The team are kept updated by any changes in the factory at weekly meetings which also cover customer requirements and during the management review meeting held annually. Audit Evidence; Toni Leach Level 3 HACCP , High Speed Training , date 13.03.2017 , cert No 2342749 Tony barker Level 2 HACCP, Advanced Food Safety , date 02.11.2018, cert No 018423

2.2 Hazard and risk analysis

The company has carried out a hazard and risk analysis in accordance with the requirements of this standard, section 2 using the 7 principles of HACCP. The documented HARM study in place at the site is at issue 1, revision 6, dated 23.08.2018 .The Hazard & Risk analysis review process takes place annually via a formal documented review meeting. The team review all aspects of study inclusive of risk assessments and documents the findings accordingly. The review was last conducted on the 31.08.2018. High hygiene risk




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category established/referenced by use of determination tree on page 9 of issue 5 of the standard with packaging defined as being in direct contact with foodstuffs. The study covers all site operations and is supported by a Process Flow Chart (Section 5.6) and Hazard Analysis. The HARM team have maintained an awareness of historical and known hazards detailed in each step of the analysis together with any product defects that may affect safety and quality. They have considered relevant codes of practice and legislative requirements. Potential hazards have been identified along with establishing hazard controls. The company has identified control measures necessary to prevent, eliminate or reduce each hazard to acceptable levels. Measures to control potential hazards and risks are in the Hazard Analysis section of the HARM System. The study is inclusive of risk assessments with a foundation of prerequisites & GMP. The scope of the study is flexographic printed , laminated, polypropylene, amorphous polyethylene, terephthalate, polyamide, surlyn, barrier coatings , antifog, metallised; APET, OPA, EVOH ,OPP, LLDPE, PvdC, slit, rewind and hot needle perforation for use as primary packaging for industries such as food, pharmaceutical, horticultural and industrial products. The analysis and covers all site processes from the purchase of raw material to the delivery of product to the customer including customer returns. Recycled material of any kind is not used. Detailed product descriptions exist for products in the form of Specification Sheets. included within specifications are material, size, thickness, colours, and packing instructions. . The study considers potential contamination sources throughout the process and the system has been developed to produce safe & legal products. The construction of the system has considered all relevant legislative requirements and are manufactured in compliance with EC 2023 / 2006 with finished products for food applications being compliant to EC1935/2004 EC 2023/2006 & EU 94/62/EC, U10/2011 & amendments. Company and Supplier DOC’s confirm compliance to all relevant industry legislation and include materials used in the manufacturing process. Flow diagram in place defines the operations on site including

Receipt and approval of artwork

Purchasing

Goods in

Slitting/perforation

Printing/lamination (Outsourced)

Finished goods storage

Despatch

Customer returns The flow chart has been verified during the last system review undertaken by the team 31.08.18. The site has considered and documented potential hazards and risks relating to all the stages of the manufacturing processes . Hazards include, unsuitable artwork, incorrect specification generated, incorrect raw material delivered , unintended migration, allergens, contamination of raw material via poor handling, contamination of WIP and finished product, outsourced print and lamination, despatch , and the potential for malicious intervention. Risk is assessed through the multiplication of likelihood and severity via 5x5 HACCP matrix methodology and given a risk rating. The likelihood and severity scores are assigned and used to calculate the risk rating, with categories in red put through the decision tree to define if it should be classed as a CCP. The team have assessed the risk levels of all identified hazards associated with the production of the packaging and deemed no hazard is classed as a CCP and all identified hazards are suitably controlled via the existing PRP’s. Hazards are controlled through the existing 18 pre‐requisite programs ranging from Supplier Control, Waste Management and allergen control. There is a separate risk assessment in place to cover the potential for malicious intervention dated 22.08.2018 ,however the company have not addressed food defence and food fraud in the study and is raised as a non‐conformance. Control measure have been documented for the identified hazards and includes SOP,s for control of all hazards including purchasing materials from approved suppliers, hygiene controls, glass controls and traceability as examples.




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The established PRP’S and SOP/ work instructions maintain product integrity to produce a safe and legal product meeting the customers’ requirements. The Hazard analysis is reviewed annually for validation, at management review meeting, at HARM meeting and through internal audits, it is at issue 1, revision 6, dated 23.08.2018. The team are reconvened to re‐evaluate the risk analysis study If or when a significant change or a product withdrawal occurs. The site reviews EC Legislation changes ,updates are controlled by the team and the company use suppliers Packaging News” and “Plastics Weekly” and websites such as the BRC Website, the government website for food contact materials (www.food.gov.uk) and the European Website for food safety (ec.europa.eu). There have been no product recalls or withdrawals since the last evaluation. Audit Evidence;

Reviewed and verified factory site plan and process and process flow chart in hazard and risk management analysis during site tour on 28TH January 2019 DOC ID ; HACCP Plan issue 1, Revision 6, dated 23.08.2018

HACCP review date 31.08.2018

Product Specification 25AAC1040DVNW 25‐micron, acrylic coated OPP 1040mm wide, Dorsett Village Nibbly Wafers

Companies regulatory compliance certificate, date 23.07.2018, signed Scott McEvoy.

VIBAC Declaration of conformity VCOAT clear film both sides acrylic coated ,signed by Alessandro Lepori, date 22.10.2018 NC1 Clause 2.2.5 .The site has not carried out a food fraud or food defence risk evaluation

2.3 Exemption of requirements based on risk analysis

No exemptions have been identified in the HARM study.

Non‐applicable clauses 2.2.8, 2.2.9, 2.3.2

3. Product safety and quality management system

3.1 Product safety and quality management system

There is a fully implemented Product Safety and Quality Management system in place designed to meet the BRC Global Standard for Packaging and Packaging Materials Issue 5 and ISO 9001;2015 requirements .The system is logical , addresses the clauses of the BRC standards , fully implemented and incorporates the HARM study. The QMS is updated and maintained by Directors and the quality manager. The system is in both hard copy and electronic format and is accessible to all key personnel on site. Individual Policies, Procedures, Sop’s and work Instructions are in place that support the system. The effectiveness of the system is reviewed during the annual Management Review Meetings and opportunities for improvement are implemented as necessary. The system is also reviewed when any changes to the company’s processes or procedures occur, including changes to the standard and is subject to internal audits. The system is available in English only. Audit Evidence; DOC ID ; QMCONTENTS, issue 7 date 25.10.2018




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3.2 Documentation control

There is a procedure for controlling documentation in place as SOP18 at issue 6, dated 14.11.17. Document control protocol is title, reference number, issue number, date and owner and complies with the requirements of the standard. Documents are controlled by document master lists and change control protocols. All changes to documents and records are recorded on the Document Log SOP18.2 at issue 2, dated 14.11.17 along with the reason for the change. Site documentation is controlled and amended when applicable by the Quality Manager or Deputy and approved by departmental heads apart from Policies which are passed to the M.D. or Operations Director for approval before re‐issue. Electronic documents are protected on password protected systems which incorporate anti‐virus controls. The computer system is managed by the site ,password protected and includes a daily back up of electronic systems Audit Evidence; DOC ID ; SOP18.2 at issue 2, dated 14.11.17. Last amendment to SOP011 Materials handling at issue 8, date 04.01.2019. Adding additional document references approved by Andy Burden Operations Manager on 04.01.2019.

3.3 Record keeping

Record Keeping is defined in the Records procedure Doc. Ref. SOP15 at issue 5 dated 24.11.2017. Hard copy records of quality inspections and approvals are held in bespoke job bags relevant to each order. Electronic records are backed up daily. Records are initialled or signed by the relevant Operator, Contractor, Supervisor or Manager. All changes to documents and records are recorded on the Document Log along with the reason for the change. The system is both computer & hard copy based. Records pertaining to product safety, legality, and integrity are maintained. The retention time for records relating to product safety, quality and legality is defined as 3 years. Examples of retained records are: ‐

PPM records

Cleaning records

Pest control records

Purchase orders

Q.C. checks

Internal audits

Supplier records

Customer complaints

Traceability tests

Product withdrawal tests Audit Evidence; DOC ID ; SOP15 at issue 5 dated 24.11.2017

Purchase order Thomas J Fudges PO No 26225, date 07.06.2018

3.4 Specifications

Specifications were challenged and found to exist for all products manufactured at the site and all raw materials. Specifications are suitably detailed and includes composition and application. Legislative requirements are detailed on the supplier DOC’s. Finished product specifications ensure compliance with relevant legislation and define if they are for food use. All products are manufactured on site conform to current legislation such as EC2023/2006, EC1935/2004 & EU10/2011. Specifications are formally agreed




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between the customer and the company after the design or specification generation process has been completed. Quotations and/or order acknowledgements are sent to customers for all orders prior to any production run taking place. The company ensures materials are safe for use with food and has Declarations of Compliance in place for all products produced at the site which are sent to Customers with each delivery. D of C’s are fully compliant with the standard and include the materials used in the composition of product, legislative requirements/compliance, no inclusion of recycled materials and defines limitations of use. Customer trademarks are used and agreed formally between all parties at the design stage, prior to any production runs as and when applicable. There is a specification review process in place. The order processing procedure includes conducting a specification review on each order by the Customer champions. All changes or amendments to existing specifications are reviewed by Sales, Production & Technical Depts. for consideration and possible implications. Manufacturers logos are not used Audit Evidence; Product Specification 25AAC1040DVNW 25‐micron, acrylic coated OPP 1040mm wide, Dorsett Village Nibbly Wafers

VIBAC Declaration of conformity VCOAT clear film both sides acrylic coated ,signed by Alessandro Lepori, date 22.10.2018

Taghleef Industries WSS transparent BOPP film specification and DOC issue No 01/2018 date 08.04.2018, signed by Satish Pawar.

Companies regulatory compliance certificate, date 23.07.2018, signed Scott McEvoy

3.5 Internal audits

There is an Internal Audit policy in place as part of the QMS, Internal audit, complaints & corrective action policy QM023 at issue 5, dated 30.07.2018. The Internal Audit policy is complemented by an Internal Audit Schedule Doc. Ref. SOP12.1 at issue 7,dated 02.01.2019 and covers all clauses in the standard. Audits are undertaken in relation to the risks associated with the activity, previous audit results and occur as a minimum annually. Audits are undertaken by Toni Leach, QA Assistant, Caroline Clay ,Quality Manager and Scott McEvoy ,Technical Engineer who have all been appropriately trained and certificates held on file. N/C’s are recorded on the Corrective Action Report Doc. Ref. SOP12.3 at issue 3, dated 24.11.2017 with root cause analysis completed as part of the investigation. N/C’s are required to be completed within 28 days and actions are verified by the auditor to ensure satisfactory closure. The audits record compliance as well as non‐compliance. Any unsatisfactory audit may result in a re ‐audit of area or process dependant on findings. Audit Evidence;

Pest Control Audit carried out by Toni Leach on 02.01.2019. Documented evidence of conformity was evident in the audit report and no N/C’s were raised.

Hygiene & Cleaning audit carried out by Toni Leach on 08.01.2019. Documented evidence of conformity was evident in the audit report and no N/C’s were raised

Viewed Toni Leach lead auditor training certificate , Benchmark business training carried out 05.10.2017.

3.6 Supplier approval and performance monitoring

The company has a supplier approval and monitoring system in place detailed in SOP14 at issue 7, dated 15.01.18. All new suppliers are subject to a site inspection by a Company Director in the first instance.




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Suppliers are also sent the “Packaging Assessment Supplier Questionnaire” which requests information regarding the company’s Management Information System, any certifications the company hold & information pertaining to the company’s performance history to supply relevant goods or services. Certification to a recognised Quality Standard such as ISO9001 or BRC Packaging is a pre‐requisite to supply Food Contact materials. Suppliers are subject to a probationary period and once fully approved added to the Approved Suppliers List are then subject to continual on‐going performance review procedures by Purchasing and Technical personnel. There is an approved Supplier list in place, only approved suppliers are used , but in the event of an exception trial orders, COA’s or DOC’s would be requested prior to using any material. Audit Evidence;

Viewed Tagheef Industries supplier questionnaire returned 29/11.2017 signed by Adriano Zamarand, ISO9001:2015 certificate from DNV‐GL cert No 14416‐2004‐AQ‐VEN SINCERT valid 28.11.2021. BRC certificate number 1322014 BRC VENSINCERT from DNV‐GL Viewed Lietpack supplier questionnaire 29.11.2017 signed Darius Kazlauskas and BRC certificate expiry date 06.03.2019 Alupol Films BRC Cert No 01 184 1541889 expiry 2019.03.09 Manucor S.p.A BRC cert No IT280004 expiry 08.04.2019 List of approved suppliers register SOP014.3 at issue 3, date 24.11.2017 showing if DOC is on file, specifications are on file ,expiry dates of certificates and dates suppliers questionnaires received back from suppliers

3.7 Management of subcontracted processes

Sub‐contractors have been employed to print and laminate films to the company’s specifications, they are all BRC and/or ISO 9001 certificated. Sub‐contractors are subject to the same controls as all other suppliers and Customers are made aware of sub‐contracted operations at design and contract review stages. All sub‐contracted work is checked by the company before being released to the Customer. Sub contacting has been evaluated in the HARM study and controls implemented and the company retails ownership of quality and legality with suitable inspections systems in place. Audit Evidence;

List of approved suppliers register SOP014.3 at issue 3, date 24.11.2017 showing if DOC on file, specifications on file and expiry dates of certificates and SQQ dates received back from suppliers.

Print Order Specification sheet 42D009P,material code AAC25340NWCCDV to fusion flexibles on 10.07.2018 showing substrate , 8 colour print required and print technical details. Print PO No 4010237

3.8 Management of suppliers of services

There is a documented procedure for the approval and monitoring of service suppliers. The approval of these suppliers is covered by SOP14 at issue 8, dated 03.12.2018. Service specifications for suppliers of services to site are in place. There is a NCR system that includes any issues identified being raised with service providers. The company require evidence to support proof of industry recognized standards such as Laboratory Services requirement 17025:2005 or ISO 9001 certification as deemed necessary. The approval process includes a supplier assessment and subsequent approval Audit Evidence; ADD Express Haulage SQQ dated 30.11.2017 signed by MD, D Fairbrother




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Blackburn Recycling supplier assessment and approval by Toni Leach on 04.06.2018 recorded on SOP‐D14.2 at issue3, 10.09.2018 Haulier Courier Logistics Ltd supplier assessment and approval by Toni Leach on 12.11.2018 recorded on SOP‐D14.2 at issue3, 10.09.2018 List of approved suppliers register SOP014.3 at issue 3, date 24.11.2017

3.9 Traceability

The company has traceability procedures in place to identify items through all stages of the manufacturing process. Reels of plain, or printed film and laminates are delivered by suppliers and are identified by Batch Numbers, Reel I.D. Nos. Supplier Name and Country of Origin. All reels are recorded on an electronically generated GRN and allocated a batch number and is the basis of traceability throughout the production process. Operators attach I.D. labels detailing Batch No. and Roll I.D. No. to every reel before wrapping and despatching. Materials are traceable via electronic and hard copy records. The Customer can identify the product from the reel label, pallet label and the delivery note. This information can be traced back to the original material used in the production of the product as labels detail Batch No., Product Description, PO No, Customer Name, Reel No. and Reel Weight. The traceability system is subject to regular testing and customers frequently request documented traceability tests. Audit Evidence; Company forward trace exercise carried out by T Leach on 04.01.2019 ,raw material supplier Manucor, material specification PL301100,PO number 0012772, delivered on 02.11.2018 raw material pallets number 002387248/9 and 002387251 in stock and pallet numbers 02387520 and 002387252 used for customer 42H046 order number 1812170019 job number 054631, product PL30366DLHW, delivery note 1812170019 On 17.12.2018. Reverse trace carried out by T Leach on 07.01.2019, Customer Ginni Enterprises Ltd, product S2G48330, batch number 0239924, order acknowledgement 181220004 production job number 054662, film supplier Alupol films on PO 0012684, goods in 17.10.2018, despatched 396 kg on 18.12.2018 ,despatch note 00102192 Full traceability demonstrated Challenged at audit Product delivered on 5.10.2018 for product code ZCODE1 for Nibbly Cheese Wafers Cheddar Cheese customer PO DVB26350 . Film 48‐micron co‐ex OPP, 2‐sided heat seal, 1560mm wide ,800mm o/d . Raw material delivered from VIBAC on PO 0012451 received 04.09.2018 . Raw material code 0023339584 sent 339 kg to Fusion flexibles Printers on 11.09.2018 PO ref number 4010237, received back 270kg on 11.09.2018, batch 002352657. Printed film checking sheet completed 25.09.2018 on SOP‐ D11‐1 at issue 2 04.09.2018 signed by Karen Lewis .Product, 270kg delivered to customer by Palletways, pallet manifest ref PB1827 on delivery note 1810050037 on 5.10.2018 signed for by J Wood Full traceability demonstrated.

3.10 Customer focus and contract review

Customer Focus & Contract Review is defined as Doc. Ref. SOP5 at issue 5, dated 02.08.2018. The Sales &Marketing Director and Sales Co‐ordinators are responsible for sales, contract review, order processing and customer satisfaction. There are reviews of customer requirements through monthly Sales meetings and daily Production Meetings. Satisfaction is monitored through complaints, annual Customer surveys and the on‐going retention of business. All N/C’s and complaints are recorded action taken. Products are produced to order and designs/specifications generated on the Redcliff MIS. Team. All customer issues and complaints are reviewed at the Management Review meetings as well as the daily and monthly meetings. Specific customer requirements are captured at design or order intake and instructions recorded and passed to




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production. Audit Evidence; DOC ID ; SOP5 at issue 5, dated 02.08.2018

Management review meeting minutes date 14.08.2018

Monthly QA meeting minutes , date 23.01.2019 Weekly production and quality ,meeting minutes, date 25.01.2019 Job Number 054954 on machine Kampf 2 , date 29.01.2019 produced by T Barker ,showing special instructions glue film to cores on production job card viewed during site tour

3.11 Complaint handling

Customer Complaints follow SOP13 at issue 9, dated 08.10.2018 customer complaints & non‐conformance. Complaints come into the business via email, phone or face to face contact. All Customer complaints are logged onto the Customer Complaint Database which is linked to the Redcliffe MIS. Complaints are recorded and investigated by the Technical Director in the first instance. The complaint is then allocated to the relevant department for investigation which includes documented root cause analysis. Corrective action is proposed and agreed, and the Customer is informed in writing of the results of the investigation and the time scale for completion. Complaints are trended and discussed at the annual Management Review Meetings. Complaints are currently below target. Audit Evidence; DOC ID ; SOP5 at issue 5, dated 02.08.2018

Reviewed complaint number D8343 ,25.05.2018 from Jordans Ryvita order number A50005/1 , issue with pallet of 490kg of product crushed and unusable. Complaint process followed and compliant with procedure

Management review meeting minutes date 14.08.2018

Monthly QA meeting minutes , date 23.01.2019 Weekly production and quality ,meeting minutes, date 25.01.2019

3.12 Management of product withdrawals, and incidents and product recalls

Product Withdrawals, Recall & Incident Management are in SOP21 Crisis & Incident Management at issue 3, dated 11.01.2018 and SOP19 Product Recall at issue 4, dated 25.09.2018 The procedures are comprehensive and fully compliant with the requirements of the standard. The procedures list the type of event that would constitute an incident e.g. allergenic contamination, flood, fire, or chemical leaks. Investigations pending a decision to withdraw a product incorporate root cause analysis, corrective action & preventative action. The incident management team is defined as the Operations Director, Quality Manager and Transport Manager. All incidents are recorded and acted upon immediately. The procedure is capable of being put into operation at any time. The Operations Director in collaboration with the Customer is ultimately responsible for withdrawal decisions. Contact lists for Customers are in place. Customer and regulatory body communications are the remit of the Quality Manager. There have been no product recall or withdrawals




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Audit Evidence; DOC ID ; SOP21 Crisis & Incident Management at issue 3, dated 11.01.2018

DOC ID ; SOP19 Product Recall at issue 4, dated 25.09.2018

Product recall test order number 28648‐S2G30370NPp, despatched 19.09.2018 ,outer pallet number 02331366 ,reel number 002331278 and002331346 ,product job number 053342 for Northumbria fine food, Carrier National delivery pick number 180925003. Contacted customer Caroline Creed 04.10.2018 who confirmed the rolls were identified and not consumed and could be recalled if needed. The product withdrawal procedure was tested and found to be compliant with the requirements of the standard.

Non‐applicable clauses 3.4.4

4. Site Standards

4.1 External standards

All external areas were reviewed during the assessment. The site comprises one large unit for warehousing and manufacturing operations. The site is located on an industrial estate in Birkenshaw on the outskirts of Bradford with no neighbouring activities posing any risk of contamination to the product. The perimeter, grounds and building fabric were found to be maintained to a high standard. There is a yard area at the rear of the site for the loading and unloading of vehicles. There are designated areas within the yard given over to waste streams with several waste skips in evidence, all clearly marked. External traffic routes are suitably surfaced, and natural drainage was observed to be adequate. All external drains are covered. Raw materials are not stored externally. The building is adequately pest proofed and there is a clear unobstructed view around the site perimeter Audit Evidence;

Site tour on 28th Jan 2019

4.2 Building fabric and interiors

Building fabric construction is steel integral frame with external steel cladding, steel cladded roofs, internal sealed painted concrete floors with painted block walls. There are painted designated walkways in production and storage areas that are well maintained with no flaking or chipped paint in evidence. Windows are shatterproof glass and pose no risk to product. No evidence of breakages evident on‐site tour. Lighting at both high and low level has protected fluorescents bulbs installed in production and warehouse areas and EFK units have shatterproof bulbs. Ventilation is adequate and of natural provision. There are no suspended ceilings in the production or storage areas only in the canteen and kitchen and are inspected by the pest control contractor. There are no internal drain openings. The building is entirely suited to the production of food contact packaging materials. Audit Evidence;





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4.3 Utilities

Water is of potable quality via mains supply provided by Yorkshire Water. It is not used in the process but utilised for cleaning purposes. Compressed air used on site is filtered, oil separated and dried. There is one compressor on site which is maintained by an external contractor Northern Compressed Air. Compressed air does not come into direct contact with any products. Audit Evidence;

Northern compressed air method statement date 22.01.2018 showing service work undertaken

4.4 Security

Site security arrangements have been risk assessed RA 001 at issue 3 ,dated 22.08.2018. The risk assessment is inclusive of potential risk from malicious intervention and has not identified any high risks as site security procedures are robust and working well. There is one secure key fob entry point for employees. The site has full CCTV and is alarmed out of hours. All visitors and contractors must report to reception and follow the signing in procedures. All visitors and contractors are supervised whilst on site. Staff are trained to challenge unauthorised personnel. There are no external silos. Audit Evidence;

Site tour on 28th Jan 2019 Auditor signing in procedure on 28/29th January 2019

4.5 Layout and product flow

There is a plan of the site in the HACCP plan showing access points for personnel, people & product flow, staff facilities and storage areas. There is an appropriate laid out, production linear flow system in operation. There is Quality Control line clearance procedures in place on changeovers. Segregation in production consists via departmental layout, for example raw material storage, manufacturing for slitting/rewinding, and finished goods storage. Sorting and removal of outer packaging takes place in the warehouse and poses no risk to the product. Audit Evidence;

Verified site plan in HACCP plan during site tour on 28th Jan 2019

4.6 Equipment

The equipment is designed specifically for its intended purpose with some of the equipment being relatively new. The machinery is being maintained to a high standard. Equipment on site comprises Kampf, Titan Dusenbury, slitter/rewinders which function as the primary production operation some of which have perforation capability. Printing and laminating are outsourced sub‐contracted operations. Notices on equipment were observed to be cleanable and secure during the site tour. New equipment is properly specified, tested and commissioned prior to use and cleaning and maintenance routines established following commissioning. Pallets and storage boxes were splintering in production or storage areas and raised as a non‐conformance. Audit Evidence;





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NC 2 Clause 4.6.3 Wooden equipment including pallets and storage boxes were splintering posing a risk of contamination

4.7 Maintenance

Defined in the Plant and Hygiene procedure QM34 at issue 4, dated 14.05.2018 and SOP010.3 maintenance plans at issue 5 ,dated 14.11.2018 and SOP010.3.1 Maintenance log at issue 4,dated 30.07.2018. Equipment is subject to condition‐based maintenance by the machine manufacturer or local contracted engineer. The system is paper based and records of completed jobs are kept on site. Contractor records were up to date and complete at the time of the assessment. Following any condition‐based maintenance, the Operator or Contractor will thoroughly check the machine before handing back to production. There is a documented clearance procedure in place for all maintenance work. Temporary modifications are recorded on the Temporary Engineering Sheet and are subject to a timed permanent solution. Tools were not observed in production. It was noted a temporary repair had been carried out on Machine 37, was not recorded and raised as a non‐conformance . Food grade greases and lubricants are used e.g. Foodlube WD Spray and Foodlube Spray Grease. There is no engineering workshop on site. Audit Evidence;

Viewed Engineering job 2H storage solutions working on mezzanine floor ,signed off as complete and fit to go into operation by A Burden Operations Manager on 13.07.2018 NC 3 Clause 4.7.6 Temporary repairs using blue tape on Machine S37, were not recorded on temporary engineering log

4.8 Housekeeping and cleaning

Housekeeping systems are in place at the site. Production staff are responsible for cleaning their own areas and there is also a dedicated contracted cleaner responsible for staff welfare areas, Active Cleaning Ltd. There are daily cleaning schedules in place in the form of Daily Inspection Pads completed by Operators. The pads inform staff what needs to be cleaned, frequency and methods of cleaning and how to clean .The schedules are compliant with the requirements of the standard and are subject to verification by Supervisors or Managers. Cleaning schedules were observed to be complete and up to date at the time of the assessment. There is a designated secure storage cupboard for cleaning equipment which was unlocked, and toilet cleaning equipment was not segregated and raised as a non‐conformance. No strongly scented chemicals were notes during the assessment. Cleaning is subject to hygiene and housekeeping internal audits Audit Evidence;

Viewed cleaning pads on S37 on 28th and 29th January during site tour completed and signed by Charlie Abel and showing machine was cleaned and line clearance checks completed Viewed weekly GMP pad check carried out by A Burden Operations manager on 21.01.2019.No issues noted NC 4 Clause 4.8.4 Cleaning equipment for toilets was not segregated from those used elsewhere and the cleaner’s cabinet was not locked

4.9 Product contamination control

4.9.1 Glass, brittle plastics, ceramics and similar materials control




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Sharps, Glass, Ceramics & brittle plastics is controlled through Doc. Ref SOP017 at issue 3,dated 31.08.2018 and the Sharps, Glass, Ceramics & brittle plastics register SOP017.1. Controls to minimise foreign body contamination are in place across all areas of the site and were observed to be effective during the assessment. No unnecessary glass, brittle, plastic or other similar materials were noted during the assessment. Light tubes are shatterproof and/or protected in production and storage areas. Glass and brittle plastic is monitored through a monthly documented glass audits undertaken by the Quality Manager or QA Assistant. There is a glass breakage procedure in place as Doc. Ref. SOP021.1 at issue 2 ,dated 14.11.2017 used to control and record all incidents Audit Evidence;

Sharps, Glass, Ceramics & brittle plastics register SOP017.1 audit 22.01.2019 completed by C Clay, QA manager Incident report 14.11.2018 broken drinking glass in canteen recorded correctly on form SOP021.1 at issue 2 ,dated 14.11.2017 and showing actions and root cause including 5 whys if appropriate The glass audit was last completed on the 04.01.2019, all items documented on the register were in satisfactory order with no issues.

4.9.2 Sharps control

Sharps control is defined in Doc. Ref. Sharps, Glass, Ceramics & brittle plastics is controlled through SOP017 at issue 3,dated 31.08.2018 and the Sharps, Glass, Ceramics & brittle plastics register. Snap off blades are not used. Stanley type knives are used and issued to each Operator and recorded on the Knife Register which is checked regularly by the shift Supervisors. There are registers in place for hand knives/blades and slitter/rewinder blades and all registers are administered by the Shift Supervisors. Registers were up to date at the time of the assessment. Used blades are disposed of in dedicated sharps containers Audit Evidence;

Viewed blade register on Kampf 1 machine check completed 08.01.2019 signed by operator M Zariff, 2 blades issued and 2 disposed in yellow sharps container with a total of 14 on machine.

4.9.3 Chemical and biological control

There is a formal control system in place for chemicals. The Quality Dept. maintains a list of approved non‐production chemicals and MSDS’s are maintained on site. The company have assessed the controls in place using the hazard analysis system for chemical and allergen contamination. These controls have been designed to prevent chemical contamination and allergen risks where appropriate. Cleaning chemicals were observed to be seen to be labelled, closed/capped with manufacturers’ instructions and stored away from production in secure designated location on the mezzanine floor at the time of the assessment. Audit Evidence;


4.10 Waste and waste disposal

Waste is managed on site in accordance with legislative requirements and split into multiple waste streams, including general waste, cardboard waste and plastic waste. The Management Team maintains the on‐site Waste Management system and general waste is compacted in the yard outside. There is a register in place




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detailing all Waste Contractors. Associated waste removes all general waste from site and Blackburn remove cardboard waste with plastic waste returned to suppliers. Arrangements are in place for the secure destruction of trademarked waste should the need arise . Waste containers are in place and are clearly marked across the site. Audit Evidence Site tour on 28th Jan 2019 Associated waste CBDU 104737 expiry 17.05.2019

4.11 Pest control

There is a Service Agreement in place with Premier Pest Control covering rodents and insects, both internal and external baits are used along with EFK’s. Premier Pest Control is a member of the BPCA Certificate Number is M15/683 valid until 28.02.2019. There are 8 routine visits, 4 Field Biologist visits and 4 EFK inspections each year including catch analysis & tube changes where applicable. The last 12 months data, shows the activity on site is very low and of no cause for concern. Last routine visit took place on the 04.01.2019 and no rodent activity or proofing issues was recorded. The visit included a service of the EFK’s & a catch analysis which recorded acceptable counts in all units. The last Field Biologist technical inspection took place on 01.08.2018 and no issues were raised requiring action. Training records are in place for the pest contractor staff who all hold relevant training certificates. A register of pesticides along with data sheets is present in the file e.g. Ratimor difenacoum wax blocks There is a site plan in place displaying all pest control devices. The pest control site plan is signed and dated on the 01.08.2018. There are 13 external bait points, 23 internal bait points and 5 EFK’s displayed on the plan. Employees are trained to recognise the signs of pest activity and must report any instances immediately to a Supervisor or Manager. Audit Evidence Training records Ben Tucker RSPH level 2 in pest management 31.01.2018 and Simon Barraclough SPH level 2 in pest management 17.05.2015. Bait plan dated 01.08.2018 showing correctly identified bait points viewed during site tour 5 and 13

Non‐applicable clauses 4.1.5 ,4.2.3 , 4.4.3, 4.7.7, 4.11.3

5. Product and process control

5.1 Product development

The procedure that cover the company’s design and development operations is Doc. Ref SOP1 Print Design & Quotation at issue 7 dated 31.07.2018. A brief will be provided by a client and the designer and technical engineer will provide the customer with options, both from a graphic artwork perspective and a technical standpoint suitable to the application in association with the sales functions. Technical specification sheets are created on site based on customer requirements and validated by technical, production & quality personnel. The Company does not design and develop products in isolation, it advises customers on appropriate standard films and laminates and receives, and processes supplied print ready artwork to the pre‐agreed customer specification. Production trials are undertaken if needed and customer trials are attended, and product testing and suitability is done at the customers premises generally attended by a member of staff. No products contain any recycled materials. All products produced are safe and legal and samples are retained in accordance with Customers requirements. Audit Evidence Factory trial on 25.01.2019 at customer CSM Bradford after reviewing brief , 30 gsm W250 PP330T supplied




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and trial attended by Scott McEvoy technical engineer at customers site. Signed off as acceptable following customer packing trials using standard machine settings by client S Gauthier on 25.01.2019 Woolly worms new design created by Ryan Serle, designer from brief received, sent to client and signed PDF approval returned on 04.12.2018 from Chris Hammond.

5.2 Graphic design and artwork control

Graphic design & artwork control is defined in Doc. Ref QMS 032 at issue 3,dated 31.07.2018 graphic artwork & design control policy and Doc. Ref. SOP2 print order new design at issue 7, dated 19.11.2018 to manage changes to artwork. Artwork file are provided by the Customer via email or FTP link, in house systems ensure artwork is checked and a final approval from the Customer received prior to sending the job to production. All new jobs are given a unique reference number. The printed product will be checked by the customers champion and recorded on printed film checking sheet Doc. Ref. SOP‐D11‐1 at issue 2 04.09.2018 for any print trials and for existing printed product on receipt. Artwork files are held on the server and are protected from malicious intervention. Audit Evidence Print specification sheet reference number 42D009P, Nibbly Wafers Cheddar Cheese for Dorsett Village ,customer material reference number AAC2534ONWCCDV signed by customer champion K Lewis on 25.09.2018 Customer artwork approval by email for Nibbly Wafers Cheddar Cheese for Dorsett Village from customer D.Studley on 02.07.2018

5.3 Packaging print control

Not undertaken on site, outsourced sub‐contracted operation via dedicated approved printing company’s all of which hold current BRC Packaging certification

5.4 Process control

The company has procedures in place to ensure effective control of all operations relating to critical product defects, production control Doc. Ref SOP010 at issue 9, dated 25.10.2018 .Control Procedures, SOP’s and prerequisites programmes are in place to ensure production of safe and legal products that meet customer requirements. The Technical, Sales, Production and Quality Depts continually review on site processes to ensure consistency of product is maintained. Established controls are in place to ensure product integrity with corresponding manufacturing work instructions and a comprehensive control of non‐conforming product procedure. Line clearance is documented on the cleaning tabs as well as hygiene and daily cleaning regimes to maintain standards of hygiene. Production specifications and machine settings are available for all products and include process limits and tolerances. Specifications are approved internally by Technical & Production personnel before a quotation is raised to the customer. There are two processes in operation on site slitting/rewinding and hot needle perforation. Machine settings include speeds and tensions. The Production Works Order defines the specification and process set up of the run and the bill of materials. Production is planned by the Shift Supervisor and production sheets are passed to Operators who set up the machinery. There is a first off inspection regime in place. All first off sheets must be signed off by the Shift Supervisor. Following first off sign off, there are in‐process inspections by operatives defined through works instructions and recorded to pre‐determined frequencies on the Production Record Sheets. Before every run of a new job, the machine is set up for the new parameters to ensure the machine is correct for the product specification and recorded on the Production Record Sheet. New specifications are raised after an approval process with the customer. Quality procedures are re‐validated to ensure conformity to specification and are verified via in‐process inspection regimes for any changes




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Audit Evidence Production record sheet and cleaning pad records 29.01.2019, on Kampf 2, operator T Barker, job number 054954 for customer , raw material reel number 002413525, customer Nairns, special instruction glue film to core. Records completed correctly, showing line clearance and start up and run checks

5.5 Calibration and control of measuring devices

There are several pieces of equipment calibrated on site in accordance with procedure Doc. Ref SOP008 at issue 4, dated 02.10.17. There is a calibration resister Doc. Ref SOP 008.1 held on site with a full list of equipment with date for next calibration and equipment serial numbers. Scales are externally calibrated under contract by D. Brash and Sons Ltd who use equipment traceable to National Standards. There are also micrometers for gauge checking on site. Equipment failure would initiate the site non‐conformance procedure which incorporates root cause analysis and corrective action. Audit Evidence Scale serial number 1124933 calibrated by brash on 06.07.2018 Micrometer serial number 176455 last calibrated on 02.11.2018 by standard calibration services

5.6 Product inspection, testing and measuring

The site has used hazard and risk principles to determine there is no need for in‐line product testing as part of the HARM study as off‐line checks are deemed suitable to guarantee the quality, safety and legality of all products produced at the site. Quality checks are undertaken by Operators at start‐up and during the production run on every reel and are recorded on the production job card. Checks include weight, treatment check, slit check, appearance and material. All pallets delivered to the finished goods warehouse carry a Q.C. Pass sticker which has been signed by the Production Operative. Checks were completed for the jobs in production during the assessment. External migration testing is undertaken by suppliers or recognised laboratories. Audit Evidence Production job card machine S37 ,operator C Abel date 29.01.2019, job number 054937 showing completed product testing QA check signed by S Bartoft production supervisor on pallet batch number 002419184, product code MB60026, job number 055022, date 28.01.2019 Migration report dated 22.10.2018 from Lab Analysis s.r.l, testing Clear BOPP Film both sides Acrylic Coated, report number 1320065/01 with migration limits conforming to guidelines set down in EU10/2011.

5.7 Control of non‐conforming product

Control of non‐conforming goods follows procedure Doc. Ref SOP13 at issue 9, dated 08.10.2018 . Any out of specification raw material or product identified during the manufacturing process is labelled and quarantined. N/C’s are recorded on the site Non‐Conformance Form. All N/C material is subject to inspection and investigation using root cause analysis. Corrective action and preventative action taken is documented on the form. Audit Evidence Raw material non‐conforming product ,order number 11798 from supplier Penhill Gulfpack 05.03.2018 CAR report shows root cause investigation and closed on 16.03.2018 Viewed quarantined product in warehouse complaint number D8343 ,25.05.2018 order number A50005/1 and identified in warehouse and on MIS system correctly




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5.8 Incoming goods

Incoming goods are checked on arrival and any non‐conforming product identified initiates the non‐conforming goods procedure .Raw materials are given a unique batch code on receipt and stored in controlled environments. FIFO is manged through the unique number using the MIS system and production planning. Any damaged pallets that arrive from suppliers are brought to the attention of the Despatch Manager and appropriate actions taken. During the assessment it was observed that raw materials and finished product were kept segregated. Audit Evidence Lietpack delivery 28.01.2019 PO number 4010389 product LAM596BSPBA, wagon checks completed ,goods in checks completed and signed and recorded by J Machin

5.9 Storage of all materials and intermediate and finished products

All raw materials and finished goods are suitably identified with labels & wrapped to avoid contamination and stored in controlled environments. During the assessment it was observed that raw materials and finished product were kept segregated. There are no hazardous chemicals on site and material for recycling is kept in dedicated containers. 4Audit Evidence; Site tour on 28th Jan 2019 Job number 055022, 6 reels stored in warehouse labelled correctly including, Prod Code MB60026 ,batch number 002419184. QA check signed SB ,28.01.2019

5.10 Dispatch and transport

All finished goods, including pallets are checked along with the vehicle before loading and must be signed off before the vehicle leaves the site in accordance with Doc. Ref SOP11 Materials Handling at issue 8, dated 04.01.2019. Signed service specifications are in place with transport organisations. Delivery drivers are supervised whilst on site, not allowed into production and must abide by the company hygiene rules. There are no company owned transport vehicles Audit Evidence; Goods out delivery note 1901310021 to Beacon Foods customer order 75422 using ADD transport on 28.01.2019 signed by JM warehouse operator, paperwork correct, and vehicle checks done

Non‐applicable clauses 5.2.4, 5.3, 5.6.3, 5.6.6 , 5.9.4, 5.10.3

6. Personnel

6.1 Training and competence

The company has an extensive training programme and will support and fund both job related and non‐role related training for all staff. Training and competence is covered by Doc. Ref SOP7 at issue 5 dated 06.03.2018. Training records define the course title, name and role of employee and the trainer. Records are signed off by both trainee and trainer. The site ensures that all staff are trained for their role within the company and staff interviewed during the evaluation were competent, trained and demonstrated competence. All new employees are subject to an induction program and issued with a Company Handbook prior to starting their employment. The induction program includes sharps, PPE, BRC/ISO presentations H&S, Fire Safety, absence, personal medicines and hygiene as examples. There is a training matrix in place




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defining the competencies of site personnel, maintained by the Quality Manager. Training is implemented on an on‐going basis and further training is identified and implemented as necessary. Staff are subject to annual appraisals by their direct report. Training records for all personnel are kept for the life of the employee and indefinitely if the employee leaves the company. Training records were challenged and were completed and signed off correctly . Audit Evidence; Training Records Reviewed Charlie Abel, Operator; Level 2 HACCP, date 03.01.2019 Advanced Food safety cert 0019352 Induction 12.01.2018, Food hygiene Advanced Food safety cert 0018412 date 02.01.2019 Josh Machin, Warehouse operator; Induction 22.05.2017 Level 2 HACCP, date 02.11.2018 Advanced Food safety cert 0018422 Tony Barker ,Operator; Personal hygiene rules 11.01.2016, slitting machine operation 28.09.2015, Level 2 HACCP, date 02.01.2018 Advanced Food safety cert 0018423, Food hygiene Advanced Food safety cert 0018413 date 02.01.2018 Doc.Ref SOP007.5 Employees skills evaluation sheet

6.2 Personal hygiene

The company personal hygiene and jewellery policy Doc .Ref QM12 at issue 3, dated 14.05.2018 only allows a plain wedding band and one pair of sleeper or continuous loop earrings to be worn in production and storage areas. There are no personal items, including mobile phones, allowed in the production areas. Personal items must be kept in lockers. Perfume or aftershave is not permitted to be worn. Personal medicines are not permitted outside of the welfare areas. All personnel, visitors and contractors, working in production areas, are required to wash their hands upon entry, after using the toilet and after eating, smoking or drinking. Cuts and grazes are covered by a blue plaster issued by First Aid personnel The policy is subject to internal audits . Audit Evidence Site tour on 28th Jan 2019

6.3 Staff facilities

Access to locker rooms is situated prior to entry into production. Visitors and contractor facilities are available at various locations around the site. Suitable lockers are provided for each employee that enables segregation of personal items and workwear. Suitably maintained and controlled hand washing facilities were seen to be in place at the site and includes the provision of warm water, unscented soap and suitable hand dryers. Hand‐washing advisory signs are displayed at point of use. Hand wash stations are located at the entrance into the production area and in all staff toilets. Toilet facilities at the site were found to be in a clean and hygienic condition at the time of the assessment and do not open directly onto production or production areas. There is a canteen provided at the site which was observed to be kept to a high standard with the provision of food storage facilities. No eating or drinking is allowed in production or storage areas. Audit Evidence Site tour on 28th Jan 2019

6.4 Medical screening

Health questionnaire is filled in prior to entry to site and the company has a return to work policy with




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employees return to work interview with managers as required, covered in induction training and site hygiene policy. All staff must complete medical questionnaire prior to employment. Staff must report medical illness and are advised of health procedures as part of their induction training. Health questionnaire must be completed by visitors/contractors to the site who will enter production area Audit Evidence Site entry procedure with medical questionnaire completed on 28/ 29th Jan 2019

6.5 Protective clothing

The site has used hazard and risk principles to determine the need for protective clothing and where it may be worn. Appropriate protective clothing was seen to be worn in production areas by staff. Employees are provided with suitable and sufficient sets of protective clothing including T‐Shirts, sweatshirts, boots, high viz coats & vests, trousers, gloves and hairnets. Beard snoods are provided as necessary. Company clothing is laundered under contract by Berendsen. Contract dated 29.05.13 (rolling). Company clothing is inspected for compliance by Line Managers. Clean and dirty clothing was observed to be kept adequately segregated during the assessment. Disposable protective clothing is used by visitors and discarded after one use. Audit Evidence Site tour 28/29th Jan 2019 Berendsen supplier audit including site visit carried out by C Clay Quality manager on 18.11.2015

Non‐applicable clauses 6.5.9

Traded Goods Module

Scope

7.1 Approval and performance monitoring of manufacturers/packers of traded food products

7.2 Specifications

7.3 Product inspection and laboratory testing

7.4 Product legality

7.5 Traceability

Non‐applicable clauses




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